SINClass II
Automated Intraoperative Spinal Rod Bending System
Orthopedic · 21 CFR 888.3070
A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod.
MDR events0All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
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Product problems
Reported product problem codes, most common first
No data available.
No trend to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code